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Innovative. Smart. Trusted. We’re your partner for sterilization products.

Monitoring Products for Vaporized Hydrogen Peroxide VH202 NAMSA’s Sterilization Products Division manufactures and markets a wide range of high quality Sterilization Table of Contents Monitoring Products used globally. Our domestic and international market segments include pharmaceutical, Biological Indicators medical device, contract sterilizers, laboratories, health care, dental, food and beverage, and biotech companies. Mini Self-Contained Biological Indicators...... 3 NAMSA is a proud manufacturer and distributor of a full line of Sterilization Monitoring Products including: Incubators...... …………………………………………..3 • Biological Indicators Inoculated Carriers & Biological Indicators...……………..4 • Chemical Process Indicators • Steel Spore Discs • Chemical Indicating Inks • Glass Fiber Spore Discs • Custom Indicator Labels • Spore Coupons & Spore Wires • Quality Control Test Suspensions Spore Suspensions...... ………………………...... …..5 • Spore Suspensions • Culture Media Prepared Culture Media...…………………………………..5 • Incubators

Our products are tailored to suit many different steril- Chemical Indicators ization processes including: Chemical Indicator Strips…………………...... …...... 6 • Steam Chemical Process Indicators...... 7 • IRRAD Irradiation Indicator Tape...... 7 • VH2 0 2 Vaporized Hydrogen Peroxide/Plasma

• Ethylene Oxide

• DRY Dry Heat

• FORM Formaldehyde

• CL0 2 Chlorine Dioxide

NAMSA’s sterilization products are manufactured in an FDA regulated facility certified to ISO 13485:2003. Globally NAMSA maintains a comprehensive list of accreditations and certifications. Please visit www. NAMSA.com to learn more.

Visit our webpage at www.NAMSA.com/Products Call us at 419-662-4345 (outside the U.S.) and 800-860-1888 (toll-free) Fax us at 419-666-1715 Email us at [email protected]

World Headquarters 6750 Wales Road Northwood, Ohio 43619 USA Biological Indicators

Mini Self-Contained Biological Indicators

NAMSA Self-Contained Biological Indicators (SCBIs) for monitoring Plasma/Vaporized Hydrogen Peroxide (VH202) sterilization processes provide fast, visible, consistent and reliable results offering peace of mind for assurance of effective sterilization. Use of NAMSA’s distinctively designed SCBI system reduces the possibility of contamination and minimizes the potential for false positives associated with post-exposure transfer. NAMSA SCBIs consist of a thermoplastic vial and a clear cap, a crushable glass ampoule with an exclusively formulated Tryptic Soy Broth (TSB) modified with pH indicator, and a steel disc inoculated with Geobacillus stearothermophilus spores. • Reduced incubation time of 24 hours • Visually distinct positive results from Purple to Yellow • Chemical Indicator on label provides instant indication of exposure • Easily activated by squeezing the sides of the vial manually or with a convenient crushing tool • Unique packaging insert keeps SCBIs in upright position and allows for quick reference to the number of units remaining in the package • Smaller size, 9 mm x 61 mm, designed to fit in challenging sterilization areas • Compliant with ISO 11138-1

Mini SCBIs Geobacillus stearothermophilus Cell Line 7953 12 month shelf-life

NAMSA Code Population Incubation Time Quantity MSCH-06 106 24 hours 100/box

Incubator The NAMSA Incubator is designed for convenient and reliable incubation of SCBIs. • The electronically-heated aluminum block holds up to 10 units • Well size: 13 mm • Temperature and incubation time are displayed digitally • Adjustable temperature (5°C to 70°C) and incubation time (0 to 99h 59m) • In 15 minutes or less, the incubator will reach the set point temperature up to 70°C • Transparent cover included to ensure consistent temperature and to protect the units • Universal 110-220V power supply • See table below for standard cord/plug options. Please inquire for other options not listed • 12 month limited warranty

Incubator

NAMSA Code Plug Configuration INC-13A North & South America, 110-220V INC-13E Europe, 110-220V INC-13U United Kingdom, 110-220V INC-13AC Australia & China, 110-220V

3 Biological Indicators

Inoculated Carriers & Biological Indicators NAMSA manufactures a comprehensive product line of Inoculated Carriers and Biological Indicators (BIs) for use in monitoring Plasma/Vaporized Hydrogen Peroxide (VH2O2) sterilization processes. The BIs are designed for monitoring processes whether placed directly into the chamber, positioned in areas of a device which are the most difficult to sterilize or distributed throughout rooms and isolators. • Convenient shelf packages of 100 units per box • Bacillus atrophaeus and Geobacillus stearothermophilus product configurations available • Room temperature storage conditions (15°C to 30°C), relative humidity of 30% to 80% is recommended • Products are accompanied by a Certificate of Analysis and are certified with population, purity, and resistance characteristics (D-value, survival and kill where applicable) • ISO 11138-1 Compliant Steel & Glass Fiber Spore Discs Spore Coupons & Spore Wires • Steel Spore Discs are 6 mm in diameter and Glass • Spore Coupons are 34 mm x 7 mm x 0.9 mm and Fiber Spore Discs are 9 mm in diameter. Packaging packaged in easy-to-access 57 mm x 70 mm Tyvek®/ is available in easy-to-access Tyvek®/Mylar® and/or Mylar® pouches (Please inquire for bulk packaging) Tyvek®/Tyvek® pouches (Please inquire for bulk & other • Spore Wires are 40 mm x 1.5 mm and packaged in bulk packaging) • Coupons and Wires have a rigid structure which allows for easy insertion and removal from a device • Spore Coupons are supplied with a hole to allow them to hang in the sterilizer or room when removed from packaging

Glass Fiber Spore Discs Spore Coupons Bacillus atrophaeus Cell Line 9372 Geobacillus stearothermophilus Cell Line 7953 12 month shelf-life 12 month shelf-life NAMSA Code Packaging Population Quantity NAMSA Code Description Packaging Population Quantity GFTN-06 Tyvek®/Mylar® 0 1 6 100/box CPS-06 Steel Coupon Tyvek®/Mylar® 106 100/box Geobacillus stearothermophilus Cell Line 7953 Bacillus atrophaeus Cell Line 9372 12 month shelf-life 12 month shelf-life NAMSA Code Packaging Population Quantity NAMSA Code Description Packaging Population Quantity GFTS-06 Tyvek®/Mylar® 0 1 6 100/box CPN-06 Steel Coupon Tyvek®/Mylar® 106 100/box

Steel Spore Discs Spore Wires Bacillus atrophaeus Cell Line 9372 Geobacillus stearothermophilus Cell Line 7953 12 month shelf-life 12 month shelf-life NAMSA Code Packaging Population Quantity NAMSA Code Description Packaging Population Quantity SDN-06 Tyvek®/Mylar® 0 1 6 100/box SWH-06 Braided Steel Bulk 106 100/box TTN-06 Tyvek®/Tyvek® 0 1 6 100/box Geobacillus stearothermophilus Cell Line 7953 12 month shelf-life Spore Discs, Spore Wires and Spore Coupons can be customized to meet your needs with population levels of 102 to 107. Please contact us NAMSA Code Packaging Population Quantity for more information. ® ® 6 SDS-06 Tyvek /Mylar 0 1 100/box Tyvek® and Mylar® are registered trademarks of E.I. du Pont de Nemours TTS-06 Tyvek®/Tyvek® 0 1 6 100/box and Company.

4 Biological Indicators

Spore Suspensions

NAMSA manufactures Spore Suspensions utilized in VH202 sterilization processes. The Spore Suspensions are pure suspensions of spores with known resistance characteristics and a variety of population levels stan- dardized per 0.1 mL. The Spore Suspensions allow for direct inoculation of products, typically to verify sterility of devices which are most difficult to sterilize. They can also be used for a variety of other microbiological tests including cleaning effectiveness studies, Bioburden percent recov- ery and Bacteriostasis/Fungistasis (BF) testing. • Pharmaceutical grade glass vials with screw cap and septum • Convenient vials of 10 mL volumes suspended in Water for Injection (WFI) • Spore Suspensions require storage under refrigerated conditions (2°C to 8°C) Spore Suspensions • Each vial of Spore Suspension is accompanied by a Certificate of Geobacillus stearothermophilus Cell Line 7953 Analysis detailing the source, assayed population, resistance charac- 24 month shelf-life teristics and expiration date • ISO 11138-1 compliant NAMSA Code Population per 0.1 mL SUS-06H 106 SUS-07H 107 SUS-08H 108

Prepared Culture Media NAMSA’s Prepared Culture Media consists of an exclusively formulated Tryptic Soy Broth (TSB) modified with pH indicator. Prepared Culture Me- dia for use with both Geobacillus stearothermophilus (GMBCP-100) and Bacillus atrophaeus (GMBTB-100) are available. A reduced incubation time for VH202 processes has been validated when NAMSA Biological Indica- tors are used in conjunction with NAMSA’s Prepared Culture Media. • Reduced incubation time of 24 hours when used with Geobacillus stearothermophilus (GMBCP-100) and 48 hours when used with Bacillus atrophaeus (GMBTB-100) • Visually distinct results: • Purple media transitions to Yellow when positive for Geobacil- lus stearothermophilus growth • Blue/Green media transitions to Yellow when positive for Bacillus atrophaeus growth • 16 mm x 100 mm flat bottom tubes of Type I borosilicate glass with screw caps • Each lot is accompanied by a Certificate of Analysis and is certified with growth promotion capabilities using Geobacillus stearothermophilus Cell Line 7953 or Bacillus atrophaeus Cell Line 9372

Prepared Culture Media 12 month shelf-life NAMSA Code Volume Quantity GMBCP-100 4 mL 100 tubes/box GMBTB-100 4 mL 100 tubes/box

5 Chemical Indicators

Chemical Indicator Strips

NAMSA is introducing a new generation of Chemical Indicator (CI) Strips for use in verifying exposure to VH202 processes. CI strips are available in three different color options, each manufactured with NAMSA’s Eco Friendly Indicating Ink technology and tear resistant substrate. CIs demonstrate exceptional performance in the most widely utilized Plasma/ Vaporized Hydrogen Peroxide Sterilizers. NAMSA evaluates the performance of every lot in state of the art equipment to ensure consistent and reliable performance. • Distinct color change will not revert • Long shelf life of 24 months • Each shipment includes a Certificate of Conformance for assurance of product quality and performance • Room temperature storage (15°C to 30°C) • Designed for Class 1 exposures at 50°C Before Exposure using 2.3 mg/L H O 2 2 Chemical Indicator • ISO 11140-1 Class 1 Compliant VH2O2

Class 1 / ISO 11140-1

LOT When exposed to VH2O2 indicator bar changes to (or brighter) Chemical Indicator – HBP-250 REF HBP-250

• Irreversible color transition from Blue After Exposure to Pink VH2O2 Chemical Indicator

Class 1 / ISO 11140-1

LOT When exposed to VH2O2 indicator bar changes to (or brighter) REF HBP-250 Before Exposure VH2O2 Chemical Indicator

Class 1 / ISO 11140-1 Chemical Indicator – HRB-250 LOT When exposed to VH2O2 indicator bar changes to (or brighter) HRB-250 REF • Irreversible color transition from Red/Pink to Blue After Exposure VH2O2 Chemical Indicator

Class 1 / ISO 11140-1 LOT When exposed to VH2O2 indicator bar changes to (or brighter) REF HRB-250

Before Exposure VH2O2 Chemical Indicator

Chemical Indicator – HRY-250 Class 1 / ISO 11140-1 LOT When exposed to VH2O2 indicator bar changes to (or brighter) REF HRY-250 • Irreversible color transition from Red to Yellow After Exposure VH2O2 Chemical Indicator

Class 1 / ISO 11140-1 LOT When exposed to VH2O2 indicator bar changes to (or brighter) REF HRY-250

Chemical Indicator Strips 24 month shelf-life NAMSA Code Description Dimensions Quantity HBP-250 Class 1 Indicator – Blue to Pink 115 mm x 19 mm 250/box HRB-250 Class 1 Indicator – Red/Pink to Blue 115 mm x 19 mm 250/box HRY-250 Class 1 Indicator – Red to Yellow 115 mm x 19 mm 250/box Ask us about NAMSA’s custom sterilization indicator program. Colors shown are representations of printed ink initial and signal colors but may vary from actual use.

6 Chemical Indicators

Chemical Process Indicators NAMSA Plasma/Vaporized Hydrogen Peroxide Chemical Process Indicators (CPIs) are manufactured with NAMSA’s Eco Friendly Indicating Inks and meet performance specifications as outlined in ISO 11140-1 Sterilization of health care products - Chemical indicators - Part 1: General requirements, for Class 1 Process Indicators. CPIs provide a fast and reliable visual check on items that were exposed to VH202. • Consistent and irreversible color transition from Yellow to Blue • No light sensitivity issues • Permanent pressure-sensitive adhesive • 24 month shelf-life • Room temperature storage (15°C to 30°C) • Each shipment is accompanied by a Certificate of Conformance to ensure product quality and consistency

Chemical Process Indicators 24 month shelf-life NAMSA Code Description Indicators Per Roll Unexposed Exposed

CPI-P03 Imprinted 12.7 mm Dots 5,000 Text reads: “Blue is H202 Exposed”

Indicator Tape

NAMSA Plasma/VH202 Tape consists of a strong custom- made white polyester substrate with a pressure sensitive adhesive which adheres to Tyvek®, plastic, woven, treated woven and non-woven wraps. The adhesive allows for secure seals yet is easy to remove. The VH202 tape is manufactured with NAMSA’s Eco Friendly Inks making it one of the most environmentally friendly and most consis- tently performing tapes on the market. • Designed to aid in distinguishing processed from unprocessed loads • Latex & Lead free • Irreversible color transition from Red to Yellow • Can be written upon • Long shelf-life of 24 months • Each shipment includes a Certificate of Conformance for assurance of product quality and performance • ISO 11140-1 Class 1 Compliant

Indicator Tape 24 month shelf-life NAMSA Code Width Length/Roll Core Diameter Quantity Before Exposure TAP-H48 18 mm 55 m 7.62 cm 48 rolls/box

After Exposure

7 Our Product Literature

Consistent. Timely. Trusted. Reliable. Accurate. Tailored. Innovative. Experienced. Precise. Your most trusted We’re with you partner for sterilization We can help you from start to finish. products and ensure the safety services. of your product.

Monitoring Products for Steam Sterilization Monitoring Products for Ethylene Oxide Monitoring Products for Gamma & E-Beam Sterilization IRRAD

IRRAD

Innovative. Secure. Precise. Smart. Tested. User-friendly. Trusted. Certified. Flexible. We’re your partner for We solve problems We’re here to verify your sterilization products. with confidence product performance. and creativity.

Monitoring Products for Dry Heat DRY

Formaldehyde FORM

Monitoring Products for Vaporized Hydrogen Peroxide VH202 Quality Control Test Suspensions - Growth Promotion Chlorine Dioxide CL02

VH202 DRY FORM CL02

Validated. Distributed by: Accurate. Trustworthy. NAMSA,the pioneers who still lead the field.

Sterilization Process Indicator Inks INKS

INKS